Quit & Fit 2.0: Feasibility and Usability Testing

October 16, 2024 updated by: Hackensack Meridian Health
Pilot randomized controlled trial to compare tobacco cessation rates of two arms: a 6-week culturally tailored tobacco cessation intervention versus a 6-week personalized culturally-tailored tobacco cessation intervention among African American women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • Nutley, New Jersey, United States, 07110
        • Hackensack Meridian Health - Center for Discovery and Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Self-identify as an African American woman
  • Currently smoke 5 cigarettes per day or more
  • Has smoked daily for the past one year
  • Able to provide informed consent
  • Generally good health as determined by medical history

Exclusion Criteria:

  • Currently pregnant
  • Diagnosis of cardiovascular disease
  • Diagnosis of lung disease
  • Diagnosis of mental illness
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Culturally-tailored Tobacco Treatment Intervention
Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will also receive weekly Culturally-tailored Content Newsletters emailed after their weekly cessation counseling session.
Behavioral: Culturally-tailored Tobacco Treatment
Weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences.
Behavioral: Culturally-tailored Content Newsletters
Weekly newsletters covering topics such as Race and Smoking, Nicotine Replacement Therapy (NRT) Reasons and Motivations for Quitting, Benefits of Quitting and other related topics.
Active Comparator: Preference-Driven Culturally-tailored Tobacco Treatment Intervention
Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will complete the one-item Control Preference Scale and receive either an Active Content Newsletter or Passive Content Newsletter emailed after their weekly cessation counseling session.
Behavioral: Culturally-tailored Tobacco Treatment
Weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences.
Behavioral: Control Preference Scale
Survey to elicit preference on the decision-making interaction with healthcare provider. The survey uses a 5 point scale from 1 to 5 with 1 or 2 points representing Active Control Preference; 3 or 4 representing a Collaborative Control Preference and 5 representing a Passive Control Preference.
Behavioral: Active Content Newsletter or Passive Content Newsletter
Based on the answers to the Control Preference Scale, participants will receive the appropriate weekly newsletter (active content or passive content). Newsletters are covering topics such as Race and Smoking, Nicotine Replacement Therapy (NRT) Reasons and Motivations for Quitting, Benefits of Quitting and other related topics presented in a more passive or active manner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the 6-week Tobacco Treatment Intervention
Time Frame: Post intervention completion - At 6 weeks
Examine the feasibility of a 6-week community-based culturally tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women by assessing the number of participants that complete all 6-week tobacco treatment calls.
Post intervention completion - At 6 weeks
Accessibility and Satisfaction of the 6-week Tobacco Treatment Intervention
Time Frame: Post intervention completion - At 6 weeks
Examine the acceptability and satisfaction of a 6-week community-based culturally-tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women using the 17-item Acceptability & Satisfaction Questionnaire. Accessibility and Satisfaction and measured using a score that ranges from 17 to 68 with higher scores representing higher Accessibility and Satisfaction.
Post intervention completion - At 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness of the Intervention (Fagerstrom Test)
Time Frame: Post intervention completion - At 6 weeks
Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using the Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a psychometrically-validated self-report 6-item tool to measure an individuals' level of nicotine dependence with a total scale score ranging from 0-10 with higher scores indicative of higher levels of nicotine dependence.
Post intervention completion - At 6 weeks
Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings)
Time Frame: 6 weeks post intervention
Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using expired air carbon monoxide readings. Higher carbon monoxide readings are associated with worse outcomes.
6 weeks post intervention
Effectiveness of Intervention
Time Frame: 6 weeks post intervention
Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using Stage of Change for Tobacco Cessation. The "Stage of Change for Tobacco Cessation" measures participants intention to quit smoking and has 4 categories: No Plans to Quit / Within the Next 6 Months/ Within the Next 30 Days / Quit. Results were compared to baseline Stage of Change.
6 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hackensack Meridian Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Carter-Bawa, PhD, Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1. Ries LAG, Melbert D, Krapcho M. SEER cancer statistics review, 1975-2005. 2008. 2. American Cancer Society. Cancer facts and figures for African Americans: 2022. 3. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;62(1):10-29. 4. Singh GK, Williams SD, Siahpush M, Mulhollen A. Socioeconomic, rural-urban, and racial inequalities in US cancer mortality: Part I-all cancers and lung cancer and part II-colorectal, prostate, breast, and cervical cancers. J Cancer Epidemiol. 2011;2011:107497. 5. Haiman CA, Stram DO, Wilkens LR, et al. Ethnic and racial differences in the smoking-related risk of lung cancer. N Engl J Med. 2006;354(4):333-342. 6. Wang Y, Beydoun MA. The obesity epidemic in the united states--gender, age, socioeconomic, racial/ethnic, and geographic characteristics: A systematic review and meta-regression analysis. Epidemiol Rev. 2007;29:6-28. 7. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2012 update: A report from the american heart association. Circulation. 2012;125(1):e2-e220.
  • 8. Dubowitz T, Heron M, Bird CE, et al. Neighborhood socioeconomic status and fruit and vegetable intake among whites, blacks, and mexican americans in the united states. Am J Clin Nutr. 2008;87(6):1883-1891. 9. U.S. physical activity statistics: 2007 state demographic data comparison. 2008. 10. Marshall SJ, Jones DA, Ainsworth BE, Reis JP, Levy SS, Macera CA. Race/ethnicity, social class, and leisure-time physical inactivity. Med Sci Sports Exerc. 2007;39(1):44-51. 11. Bassuk SS, Manson JE. Physical activity and cardiovascular disease prevention in women: A review of the epidemiologic evidence. Nutr Metab Cardiovasc Dis. 2010;20(6):467-473. 12. Glasgow RE, Lichtenstein E, Marcus AC. Why don't we see more translation of health promotion research to practice? rethinking the efficacy-to-effectiveness transition. Am J Public Health. 2003;93(8):1261-1267. 13. Swan GE, Ward MM, Carmelli D, Jack LM. Differential rates of relapse in subgroups of male and female smokers. J Clin Epidemiol. 1993;46(9):1041-1053. 14. Pirie PL, Murray DM, Luepker RV. Gender differences in cigarette smoking and quitting in a cohort of young adults. Am J Public Health. 1991;81(3):324-327. 15. Pomerleau CS, Zucker AN, Namenek Brouwer RJ, Pomerleau OF, Stewart AJ. Race differences in weight concerns among women smokers: Results from two independent samples. Addict Behav. 2001;26(5):651-663.
  • 16. Berg CJ, Thomas JL, An LC, et al. Change in smoking, diet, and walking for exercise in blacks. Health Educ Behav. 2012;39(2):191-197. 17. Ussher MH, Taylor AH, Faulkner GE. Exercise interventions for smoking cessation. Cochrane Database Syst Rev. 2014;8:CD002295. 18. Marcus BH, Albrecht AE, Niaura RS, Abrams DB, Thompson PD. Usefulness of physical exercise for maintaining smoking cessation in women. Am J Cardiol. 1991;68(4):406-407. 19. Marcus BH, King TK, Albrecht AE, Parisi AF, Abrams DB. Rationale, design, and baseline data for commit to quit: An exercise efficacy trial for smoking cessation among women. Prev Med. 1997;26(4):586-597. 20. Marcus BH, Albrecht AE, King TK, et al. The efficacy of exercise as an aid for smoking cessation in women: A randomized controlled trial. Arch Intern Med. 1999;159(11):1229-1234. 21. Marcus BH, Albrecht AE, Niaura RS, et al. Exercise enhances the maintenance of smoking cessation in women. Addict Behav. 1995;20(1):87-92. doi: 0306460394000484 [pii]. 22. Marcus BH, Lewis BA, King TK, et al. Rationale, design, and baseline data for commit to quit II: An evaluation of the efficacy of moderate-intensity physical activity as an aid to smoking cessation in women. Prev Med. 2003;36(4):479-492. 23. Whiteley JA, Napolitano MA, Lewis BA, et al. Commit to quit in the YMCAs: Translating an evidence-based quit smoking program for women into a community setting. Nicotine Tob Res. 2007;9(11):1227-1235.
  • 24. Webb MS, Baker EA, Rodriguez de Ybarra D. Effects of culturally specific cessation messages on theoretical antecedents of behavior among low-income african american smokers. Psychol Addict Behav. 2010;24(2):333-341. 25. Travier N, Agudo A, May AM, et al. Longitudinal changes in weight in relation to smoking cessation in participants of the EPIC-PANACEA study. Prev Med. 2012;54(3-4):183-192. 26. Filozof C, Fernandez Pinilla MC, Fernandez-Cruz A. Smoking cessation and weight gain. Obes Rev. 2004;5(2):95-103. 27. Grunberg NE. A neurobiological basis for nicotine withdrawal. Proc Natl Acad Sci U S A. 2007;104(46):17901-17902. 28. Mineur YS, Abizaid A, Rao Y, et al. Nicotine decreases food intake through activation of POMC neurons. Science. 2011;332(6035):1330-1332. 29. Seeley RJ, Sandoval DA. Neuroscience: Weight loss through smoking. Nature. 2011;475(7355):176-177. 30. Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2012;11:CD006611. 31. Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2006;(3)(3):CD002850. 32. Mottillo S, Filion KB, Belisle P, et al. Behavioural interventions for smoking cessation: A meta-analysis of randomized controlled trials. Eur Heart J. 2009;30(6):718-730. 33. Migneault JP, Dedier JJ, Wright JA, et al. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive african-americans: A randomized controlled trial. Ann Behav Med. 2012;43(1):62-73. 34. Mobile technology fact sheet. http://www.pewinternet.org/fact-sheets/mobile-technology-fact-sheet/. Updated January 2014.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2022-0894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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